a clinical trial of tq05105 tablets in the treatment of moderate and high risk myelofibrosis

Conditions: Moderate and High Risk Myelofibrosis

Summary: q05105 tablet is a janus kinase 2 (jak2) inhibitor, which can be used to treat jak2 target related diseases, such as moderate or high-risk multiple myelofibrosis


Eligibility criteria:
inclusion criteria: 1. the subjects volunteered to join the study and signed informed consent, with good compliance; 2. age: 18-75 years old (when signing the informed consent form); eastern cooperative oncology group (ecog) performance status (ps) score: 0-2; the expected survival time is more than 24 weeks; 3. primary myelofibrosis (pmf) was diagnosed according to world health organization (who) standard (2016 edition), or post polycythemia vera(pv)-mf or post essential thrombocythemia (et)-mf was diagnosed according to international working group-myeloproliferative neoplasms research and treatment (iwg-mrt) standard; jak2 mutation or not was included in the study; 4. according to dynamic international prognostic scoring system (dipss) prognosis grading criteria, the patients with myelofibrosis were assessed as medium risk (including medium risk-1, medium risk-2) or high risk; 5. splenomegaly: palpate the splenic margin at least 5cm below the ribs (the distance from the costal margin to the farthest point of splenic protrusion); 6. peripheral blood primordial cells ≤ 10%; 7. if anti myelofibrosis therapy (except jak inhibitor) is being received before screening, the drug must be stopped at least 4 weeks before the random date; 8. no growth factor, colony stimulating factor, thrombopoietin or platelet transfusion was received within 2 weeks before the examination, and hemoglobin (hgb) ≥ 80g / l, platelet count (plt) ≥ 100 within 7 days before the random date × 10\^9 / l and neutrophil absolute value (neut) ≥ 1.0 × 10\^9/l; 9. the main organs were functional 7 days before the random date, which was in accordance with the following criteria: total bilirubin (tbil) was less than 2 times the upper limit of normal value (uln); alanine aminotransferase (alt) and aspartate aminotransferase (ast) were less than 2.5 times of uln; serum creatinine (cr) \< 1.5 times of uln or creatinine clearance rate (ccr) ≥ 50ml/min; the blood coagulation function should be checked in accordance with: prothrombin time (pt), activated partial thromboplastin time (aptt), international standardized ratio (inr) \< 1.5 × uln (not anticoagulant treatment); left ventricular ejection fraction (lvef) evaluated by color doppler ultrasonography ≥ 50%; 10. female subjects of childbearing age should agree to use contraceptive measures (such as intrauterine device, contraceptive or condom) during the study period and within 6 months after the end of the study; the serum pregnancy test was negative within 7 days before the date of randomization and must be non lactating subjects; male subjects should agree to use contraception during the study period and within 6 months after the end of the study period. exclusion criteria: 1. those who have received allogeneic stem cell transplantation in the past, or autologous stem cell transplantation within 3 months before the random date, or recently planned stem cell transplantation; 2. patients who have received jak inhibitors in the past; 3. those who had undergone splenectomy or received splenic radiotherapy within 6 months before the date of randomization (including internal and external radiotherapy); 4. other malignancies were present or present within 3 years before the date of randomization. the following two cases can be included: other malignant tumors treated by single operation have achieved 5-year disease-free survival (dfs) in a row; cured cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor \[ta (non-invasive tumor), tis (carcinoma in situ) and t1 (tumor infiltrating basement membrane)\]; 5. patients with multiple factors (such as inability to swallow, postoperative gastrointestinal resection, acute and chronic diarrhea, intestinal obstruction, etc.) affecting oral or absorption of drugs; 6. non hematological toxicity caused by previous treatment did not return to ≤ 1 (excluding alopecia); 7. patients who received major surgical treatment or had obvious traumatic injury within 4 weeks before the date of randomization; 8. at present, there are congenital bleeding or coagulation diseases, or are using anticoagulant therapy; 9. arteriovenous thrombotic events occurred within 6 months before the random date, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; 10. a history of psychotropic substance abuse or mental disorder; 11. active or uncontrolled severe infection (≥ common terminology criteria for adverse events(ctcae)2 infection); 12. hepatitis b virus (hbv) dna≥uln； hepatitis c antibody positive and hepatitis c virus (hcv) rna ≥ uln; 13. myocardial ischemia or myocardial infarction, arrhythmia, qt interval prolongation (corrected qt interval (qtc) ≥ 450 ms for male, qtc ≥ 470 ms for female) and congestive heart failure (nyha classification) of grade 2 or above; 14. blood pressure control is not ideal (systolic blood pressure ≥ 150 mmhg or diastolic blood pressure ≥ 100 mmhg); 15. renal failure requires hemodialysis or peritoneal dialysis; 16. newly diagnosed pulmonary fibrosis or drug-related interstitial lung disease within 3 months before the date of randomization; 17. history of immunodeficiency, including human immunodeficiency virus (hiv) positive or other acquired or congenital immunodeficiency diseases, or organ transplantation; 18. patients with epilepsy and need treatment; 19. had received chemotherapy, radiotherapy or other anti-cancer therapy within 4 weeks before the date of randomization; 20. within 2 weeks before the date of randomization, he received chinese patent medicines (including compound cantharis capsule, kang'ai injection, kang'laite capsule / injection, aidi injection, brucea javanica oil injection / capsule, xiaoaiping tablet / injection, cinobufagin capsule, etc.) with anti-tumor indications specified in nmpa approved drug instructions; 21. uncontrolled pleural effusion, pericardial effusion or ascites; 22. patients with central nervous system involvement; 23. there was a history of live attenuated vaccine inoculation within 4 weeks before the date of randomization or live attenuated vaccine inoculation was planned during the study period;